ITMO public health
Last update : 11/08/2021 | Version : 1 | ID : 74090
| General | |
| Identification | |
| Detailed name | Identification of factors allowing a therapeutic anemia management optimization in CKD patients treated with C.E.R.A. |
| Sign or acronym | OPTICERA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | ML39300 |
| General Aspects | |
| Medical area |
Urology, andrology and nephrology |
| Study in connection with Covid-19 |
No |
| Pathology (details) | Anemia in Chronic Kidney Disease |
| Health determinants |
Medicine |
| Keywords | Méthoxy-polyéthylène glycol-époétine bêta |
| Scientific investigator(s) (Contact) | |
| Name of the director | Roche Medical data center |
| Address | 4 cours de l'Ile Seguin - 92100 Boulognne-Billancourt |
| data_sharing.france@roche.com | |
| Organization | Roche SAS |
| Collaborations | |
| Participation in projects, networks and consortia |
No |
| Funding | |
| Funding status |
Private |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Roche SAS |
| Organisation status |
Private |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective |
Primary Objective: To identify the potential factors of optimizing the therapeutic management of renal anemia with C.E.R.A.
Secondary Objectives: - Analysis of the therapeutic response to C.E.R.A., according to 4 definitions (reach or maintenance of the Hb concentration within the therapeutic target range of [10-12] g/dL, limitation of Hb variability at +/- 1 g/dL from the baseline value, both above criteria, or at least one of the above criteria, after a 3-month treatment period) - Description of patient and disease characteristics at first C.E.R.A. injection - Description of the evolution of CKD management (physical examination, laboratory parameters including Hb values and renal function, prior and ongoing concomitant treatments for anemia, as well as concomitant diseases and treatments) under C.E.R.A. treatment - Search for any associations/correlations between variables and detection of particular profiles. |
| Inclusion criteria |
Inclusion criteria:
- CKD patients having started C.E.R.A. treatment at inclusion - With at least one Hb value within the 3-month period prior to the first C.E.R.A. injection - With no participation in an interventional study |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | D63 - Anaemia in chronic diseases classified elsewhere |
| Gender |
Male Woman |
| Geography area |
National |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Date of last collection (YYYY or MM/YYYY) | 2015 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 2984 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Pooling of 5 non-interventional studies with Mircera® (OCEANE / HORTENSIA / COMETE / PERCEPOLIS / MIRIADE). Type of data collected : demographics, comorbidities, CKD history, prior treatments for anemia, laboratory data, first C.E.R.A. injection, other treatments, vital signs, treatment for anemia, C.E.R.A. injections, other treatments, early withdrawal. |
| Presence of a biobank |
No |
| Procedures | |
| Data collection method | Pool of 5 non interventional databases |
| Classifications used | CDISC like |
| Quality procedure(s) used | GCP/GVP |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the referring doctor |
| Followed pathology | N18 - Chronic kidney disease |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Dedicated website | https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html |
| Presence of document that lists variables and coding procedures |
Yes |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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